Clinical Trial Reports: September 2007

By Querida Anderson
Published: Thursday, Jul 08, 2010
%u25BA PHASE IV

Obesity a Major Risk Factor for Multiple Myeloma


Investigators following the continuing natural histories of the more than 135,000 people enrolled in the Nurses Health Study and the Health Professionals Follow-up Study have confirmed a suspected link: obesity and multiple myeloma. They found that increasing body mass index (BMI) correlates with increasing incidence of multiple myeloma.

The authors of an article appearing in the July 2007 issue of Cancer Epidemiology, Biomarkers & Prevention indicated that 215 cases of multiple myeloma had been confirmed among the two studies’ 136,623 participants. The incidence of multiple myeloma was twice as high in men with a BMI of 30 kg/m2 compared with patients whose BMIs were below 22 kg/m2. The incidence of multiple myeloma but the effect was not as strong.

  Risk of Multiple Myeloma in Relation

  to Body Mass Index


  Reference Group   Relative Risk
  Men with BMI < 22.0 kg/m2   1.0
  Men with BMI ≥ 30 kg/m2   2.4
  Women with BMI 25–29.9 kg/m2   1.6
  Women with BMI ≥ 30 kg/m2   1.2


The researchers believe that this research indicates that people can help reduce their risk of multiple myeloma, although it is not known why the relative risk is more low in lean individuals compared with those of normal body weight (BMI, 25 kg/m2).


   Birmann BM, Giovannucci E, Rosner B, et al: Body mass index, physical activity, and risk of multiple myeloma. Cancer Epidemiol Biomarkers Prev 2007;16:1474-1478.







%u25BA PHASE III

Long-Term Safety of Adjuvant Trastuzumab (Herceptin)




Adjuvant trastuzumab (T) for the treatment of early-stage breast cancer with human epidermal growth-factor receptor-2 (HER-2) overexpression has been shown to reduce recurrence and increase survival. Long-term safety issues are still in question, however, especially regarding long-term cardiotoxicity and specific patterns of relapse such as brain metastases. Italian researchers recently assessed the magnitude of those two risks by performing a literature-based meta-analysis.

Five randomized clinical trials were included in the evaluation, totaling 11,187 patients. The follow-up in these trials averaged two years. Three of the trials reported results for brain metastases (6,738 patients). A significant increased risk of grade III or IV congestive heart failure was found in the trastuzumab arm (absolute difference, 1.61 percentage points; P < .00001). The authors note that this can be interpreted to mean that 62 patients must be treated to reveal harm to one.

They also observed a higher risk of asymptomatic leftventricular ejection fraction reduction in the patients taking trastuzumab (absolute difference, 7.20 percentage points; P < .00001). These researchers from the Regina Elena National Cancer Institute in Rome found that the incidence of brain metastases was significantly greater in the trastuzumab arm of the trials (absolute difference, 0.62 percentage points; P = .033). This small absolute difference translates into 161 patients having to be treated for one to have brain metastases.

Rates for disease-free survival and overall survival were significantly better in the trastuzumab arms of each of these trials. The authors conclude that although trastuzumab has been shown to be an important oncological discovery, “the biological activity of the drug needs to be investigated more extensively for long-term safety and specific relapse patterns.”




   Bria E, Cuppone F, Fornier M, et al: Cardiotoxicity and incidence of brain metastases after adjuvant trastuzumab for early breast cancer: The dark side of the moon? A meta-analysis of the randomized trials. Breast Cancer Res Treat July 19, 2007 (E-pub, ahead of print).





%u25BA PHASE III

Bevacizumb (Avastin) Helps Slow Tumor Growth in Patients with Advanced Non-Small-Cell Lung Cancer



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